Vaccine Patents in India
03 December 2012
India is emerging as a key vaccine producer and already produces 43% of the global health vaccines. India’s domestic vaccine market is reported at around US$900 million and is expected to grow at a rate of 23% until 2013. Exports have a major share in the Indian vaccine market, with 70% of all vaccines produced being exported. Key drivers of this phenomenon are relatively lower costs in manufacturing, a large pool of scientific talent and skilled manpower, world class research and development facilities with the ability to produce and develop high quality vaccines, lower costs of clinical trials, new strategic alliances and the recent catalyst for stupendous growth in this sector is product patent regimen.
Currently, US$280 million of the domestic market is the domain of just 20 players. These manufacturers are preferred for their high-volume supplies to the government’s universal immunization programme, since these companies provide affordable vaccines. Global vaccine giants such as GlaxoSmithKline (GSK), Sanofi Pasteur and others have approximately 50% of the private market. The presence of just a few players is primarily due to stringent requirements for high quality standards. Among domestic companies, key players are Serum Institute of India, Panacea Biotech, Bharat Biotech, Biological E and Indian Immunologicals.
Serum Institute of India is the world’s largest producer of the measlesmumps- rubella (MMR) and diphtheriapertussis-tetanus (DTP) vaccines, supplying more than 140 countries. The Institute produces several recombinant and combination vaccines and so far has nine granted patents.
Panacea Biotech produces hepatitis B vaccine, monovalent oral polio type I and type III vaccines and several combination vaccines, like DPT+Hepatitis B+HIV. Its patent portfolio of 31 patents includes two for polio vaccines. Bharat Biotech has six patents in India including a patent for vaccine for staphylococcal infection. Indian Immunologicals deals with veterinary science and medicines and produces a wide range of cattle and canine vaccines and viral vaccines including human papillomavirus (HPV), which are under the umbrella of four patents. Zydus Cadila’s research and development work has so far resulted in securing one patent for salmonella fever; patent applications for vaccines for measles, malaria, HPV and cancer are currently pending with the patent office.
In addition to private sector companies, government agencies and government-funded institutes are also working on vaccines. The National Institute of Immunology has secured four patents related to Japanese encephalitis vaccines, immunocontraceptive vaccines and vaccines for enhancing immunological memory. The Council of Scientific and Industrial Research has a patent for a leishmaniasis vaccine development, the Bose Institute for a new tuberculosis vaccine and Rakesh Bhatnagar of Jawaharal Nehru University for a Bacillus anthracis vaccine.
With India’s IPR laws improving considerably, confidence of foreign investors is growing, resulting in investments by multinational corporations. The largest players want to strengthen their presence in India and have geared up to launch their vaccines in the India. Companies like GSK, Merck, Sanofi Pasteur and Eli Lilly are launching a number of vaccines in the country.
GSK, with a 29.3% market share, has been aggressively developing vaccines for diseases specific to the Indian subcontinent such as malaria, dengue fever, typhoid and hepatitis E. Among its 275 patents granted in India, 15 have been granted in the field of vaccines, including vaccines for HIV, malaria, hepatitis C, hepatitis B and HPV. Patents have been granted for multivalent vaccines as well.
Merck has secured 483 Indian patents, six for vaccines relating to hepatitis C, HPV and Marek’s disease. Sanofi Pasteur enjoys a 22% market share and has submitted patent applications for many vaccines including viral vaccines for influenza B, meningitis and dengue fever. It acquired Shantha Biotech in 2008, indicating expansion plans of the company.
Pfizer is not selling any of its vaccines in India; however, its acquisition of Wyeth has provided it a space in the Indian vaccine market. Wyeth has filed patent applications for infectious bronchitis vaccine and pneumococcal polysaccharide vaccine. In addition, both Pfizer and Wyeth have several applications filed for veterinary vaccines including vaccines against canine influenza, rabies and a mycoplasma vaccine against pneumonia.
Chiron, now part of Novartis, has set up a plant in India and has secured four patents for vaccines related to Neisseria meningitis. Rican has patented a vaccine for Heliobacter pylori infection. The Institute of Immunology has been granted a patent for hepatitis B vaccine. Intervet International, now owned by Merck, has secured a patent for a rabies vaccine. Many companies like Genecure and Bionor Immuno have been successful in securing patents for HIV vaccine compositions.
With 25 million babies being born every year and increasing awareness and purchasing power of the population, India’s vaccine sector is poised to storm the business world in coming years. While multinationals are gearing for making aggressive moves by launching new patented vaccines in the market, domestic players are also balancing the competition by providing high-quality affordable vaccines. The vaccine market in India is sufficiently large for many players to compete; it will be well-entrenched players coming with India-specific strategies which will make the mark.
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